The company says it asked the FDA to justify the need for the study: 'We’ve done all required studies except one: A dog study where you treat dogs for nine months. Then you kill the dogs and look at their organs'.
ALEX GANGITANO: ‘A pharmaceutical company is challenging the Federal Drug Administration (FDA) for requiring animal testing of a new drug in a high-stakes lawsuit. The case has attracted the attention of animal rights activists and lawmakers, putting a new spotlight on the agency’s guidelines on animal tests. Vanda Pharmaceuticals, a Washington, D.C.-based company, was told by the FDA to conduct a nine-month study on dogs of their new drug tradipitant, a treatment for gastroparesis, a stomach disorder affecting mostly women that can cause death. The company conducted a clinical trial of the drug on 150 human volunteers for up to three months and asked the FDA in 2018 for permission to continue the study for longer. “That’s the start of the problem,” Vanda CEO Mihael Polymeropoulos told The Hill.
“The FDA explicitly told us — based on a guidance, which is a recommendation, not binding — that in order to expose patients to more than three months treatment, certain studies have to be done,” he said. “We’ve done most of them except one: a dog study where you treat dogs for nine months. Then you sacrifice the dogs and you look at their organs.” The company says it asked the FDA to justify the need for the study and that the agency did not. It then filed suit to continue testing on humans…
Animal rights groups, who have long sought to reduce or eliminate animal tests, have backed Vanda. “We’ve often heard behind the scenes that companies are being asked for data using animals that doesn’t necessarily make sense,” said Kathleen Conlee, the Humane Society’s vice president of animal research issues. She said in most cases, companies fall to pressure “to just do the test to move the product along.” Conlee said she has not seen another company publicly take a stand in her 20 years working on animal testing issues. Both Vanda and animal rights groups are pressuring Congress to act on animal testing’. SOURCE…
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